Experimento 2 Identificación de respuestas emocionales coherentes

4.2.1.1. Containment of animals

The most obvious form of containment is the physical containment of the biopharm animals themselves. ERMA has required with regard to existing biopharm research facilities that the outdoor containment facility be enclosed by a two-metre-high double perimeter fence with an inner fence electronically monitored and alarmed to enable location of any breach of containment. The fence should be constructed in accordance with MAF’s Containment Standard for Field Testing of Farm Animals, which prescribes

the materials to be used and the method of construction. It also mandates that the area between the two fences shall be clear, “so that if animals gain access they can be easily seen”.

In the event containment is breached, ERMA has required that the operator recover the escaped cattle. If there has been any possibility of mating during the escape, affected cows must be destroyed or any pregnancies that may have resulted from the escape aborted. Presumably this applies to neighbouring conventional cows (in case of an escaping bull) as well as to any escaping biopharm cows. The MAF inspector responsible for the facility must be notified within 24 hours.

The ERMA approvals require that no genetically modified cattle, surrogate mothers (cows carrying GM foetuses to full term or near to full term), or recipient cows (cows that receive a GM embryo but subsequently lose the foetus) be permitted to leave the outdoor containment facility except in accordance with the Containment Standard for Field Testing of Farm Animals. Permission for this must be sought from the facility’s MAF

inspector, and any transport of animals must be in a sealable, towable conveyance, which

22 _{Some of the controls imposed by ERMA on GMD02028 were intended to ensure that the distinction}

between “development” and “field trial” was maintained. For example: “Breeding shall be limited to the minimum necessary to complete development. No breeding of animals is allowed, except where necessary to ensure that 'true to type' animals have been produced and to investigate stability of inheritance.”

must be sealed by the inspector before transfer. The conveyance, including effluent tanks, must be cleaned after unloading. Further, the animals are to be transported directly to the receiving facility and:

[t]he driver shall be given contact phone numbers in the case of an emergency. A sign shall be displayed in the cab which states: "In the event of an accident or emergency phone these contact phone numbers as soon as possible." These numbers shall be readily available in the cab.

It seems likely that, in order to facilitate containment, limitations would be imposed on the number of animals allowed on any particular farm. It is unclear whether transgenic bulls would be needed or permitted on the farm. It is quite possible that the commercial biopharm operation would not produce its own replacement animals (see Scenarios 1-3 above); if it did, presumably frozen semen from founder bulls could be used through artificial insemination. It may be considered that transgenic bulls would pose the greatest escape risks; given that other less risky methods of replacement are available, controls may involve the exclusion of transgenic bulls.

4.2.1.2. Identification of animals and facility

In order to facilitate recapture of escaped animals and to prevent inadvertent contamination of the conventional milk supply through mishandling, there must be robust identification methods for biopharm animals. ERMA currently requires that: all conventional cattle within the facility be double tagged; all genetically modified cattle be individually identified by an ear tag and also implanted with a subcutaneous electronic microchip for individual electronic identification; and in the event that subcutaneous microchips cannot be implanted until cattle reach a certain age, cattle without microchips shall have two different types of ear tags in place at all times to allow for immediate identification. The GMF98009 approval requires that the identification system include a database from which information on individual genotype and generation can be derived, and both approvals require that a register be maintained with records of identity and fate of all cattle in the operation.

The Containment Standard also requires that the facility itself be clearly identified: “A

prominent sign shall be displayed at the entrance(s) to indicate that the premises is [sic] a

containment facility and that unauthorized entry is prohibited.”

4.2.1.3. Disposal of carcasses

ERMA has mandated the method of carcass disposal in all biopharm approvals. In the case of the PPL sheep, this was to be through on-site or off-site incineration. In the case of the cattle research in GMF98009 and GMD02028, it has mandated burial:

Disposal shall be by burial in unlined offal pits. Offal pits are to be located within the outdoor containment facility and shall be positioned to minimise leaching to groundwater. The applicant shall consult with Ngāti Wairere with respect to

developing culturally appropriate mechanisms and protocols for disposal, which add to and are consistent with the rest of this control. (ERMA 2002)

It has also mandated that “in the event of mortality in genetically modified cattle in the containment facility, carcasses shall be immediately removed to prevent access by scavengers.”

In the relevant GMF98009 decision, conventional cows that failed to become pregnant after embryo implantation were permitted to be sold or disposed of off-site 50 days after three negative pregnancy tests administered 28, 35 and 50 days after embryo transfer. Conventional surrogate cows that have given birth to a transgenic calf were also allowed to be disposed of off-site after a withholding period of at least 100 days to ensure that no foetal blood cells remained (ERMA, 2001: 13, 42). In decision GMD02028, however, it was decided that it was not appropriate to distinguish between recipient cows (conventional cattle that have failed to carry a transgenic embryo to term) and surrogate mothers (conventional cattle that have given birth to transgenic calves) for the purposes of disposal – both of these, as well as offspring that are non-transgenic, should be disposed of on-site, through burial in the manner described above (ERMA, 2002: 18-19).

4.2.1.4. Containment of milk

ERMA currently requires that milking take place within the containment facility and that milk be transported in secure containers to a processing facility registered as meeting the requirements of the MAF Biosecurity Authority/ERMA New Zealand Standard

Containment Facilities for Microorganisms. In addition to containment requirements, a

facility for extraction of pharmaceutical substances would be likely to operate under additional requirements for assuring the safety of the product.

ERMA also currently requires that the quantity of milk produced and its fate be logged in a register. Any surplus milk and milk components would presumably be subject to the same prescriptions for disposal that currently apply to all of the milk produced in the approved research, namely: destroyed on site, by an effluent treatment digester, incineration, or spraying onto pasture following treatment to destroy any cells present. It may also happen that different proteins are produced on the same farm. In this situation cows would need to be managed as separate herds and their milk segregated. This would add on-farm segregation and containment issues even for an exclusively biopharm operation, in the interests of protecting the integrity of the product.

4.2.1.5. Protection of the food chain

ERMA currently requires of approved biopharm research operations that they ensure that no part or product of any animal involved in the operation—including inter alia surrogate

mothers, recipient cows and non-transgenic calves—enter the food chain or “be ingested by any person at any time”.